United States District Court, N.D. California
For Center for Food Safety, Center for Environmental Health, Plaintiffs: George Andreas Kimbrell, LEAD ATTORNEY, PRO HAC VICE, Paige Michele Tomaselli, LEAD ATTORNEY, Center For Food Safety, San Francisco, CA.
For MD Margaret A. Hamburg, Commissioner of U.S. Food and Drug Administartion, Defendant: Gerald Cooper Kell, LEAD ATTORNEY, U.S. Dept. of Justice, Consumer Protection Branch, Washington, DC.
For Tanimura & Antle Fresh Foods, Inc., Amicus: Jeffrey L. Bornstein, LEAD ATTORNEY, K& L Gates LLP, San Francisco, CA; Jason Nathaniel Haycock, K L Gates LLP, San Francisco, CA.
ORDER RE CROSS-MOTIONS FOR SUMMARY JUDGMENT
PHYLLIS J. HAMILTON, United States District Judge.
The parties' cross-motions for summary judgment came on for hearing before this court on March 27, 2013. Plaintiffs appeared by their counsel George Kimbrell, and defendant appeared by her counsel Gerald Kell. Having read the parties' papers and carefully considered their arguments and the relevant legal authority, the court hereby GRANTS plaintiffs' motion and DENIES defendant's motion as follows.
This is an action brought by plaintiffs Center for Food Safety and Center for Environmental Health against Margaret Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration (" FDA" ), pursuant to the Administrative Procedures Act (" APA" ), 5 U.S.C. § 551, et seq. Plaintiffs seek declaratory and injunctive relief regarding the failure of the FDA to promulgate final regulations by mandatory deadlines contained in the FDA Food Safety and Modernization Act of 2010 (" FSMA" ), Pub. L. No. 111-353, 124 Stat. 3885 (2011) (codified in scattered sections of 21 U.S.C. § 301 et seq., as amended).
Congress enacted the FSMA - which was signed into law on January 4, 2011 - to modernize food safety laws and regulations by mandating science-based standards and controls; by providing the FDA with greater authority to prevent and address food safety hazards by taking steps to prevent them from occurring; by strengthening the FDA's inspection and enforcement powers; and by improving coordination among federal, state, and foreign food safety agencies. See H.R. Rep. No. 111-234 (2009) at 35-40. To this end, Congress directed the FDA to promulgate new regulations in seven areas, within 18 months of the effective date of the FSMA.
The seven major food safety regulation areas, and the implementation dates listed in the legislation, are as follows:
(1) regulations with regard to establishing science-based minimum standards for conducting hazard analysis, documenting hazards, implementing preventing controls, and documenting implementation of preventive controls, as required by 21 U.S.C. § 350g(n)(1) (regulations to be promulgated " [n]ot later than 18 months after January 4, 2011" - or July 4, 2012);
(2) regulations with regard to (a) activities that constitute on-farm packing or holding of food not raised or consumed on such farm or another under the same ownership for purposes of
§ 415 of the Food, Drug, and Cosmetic Act; and (b) activities that constitute on-farm manufacturing or processing of food not consumed on that farm or on another farm under common ownership for purposes of § 415, as required by provision that the FDA must clarify activities included as part of definition of " facility," pursuant to 21 U.S.C. § 350d note (" notice of proposed rulemaking" to be published in Federal Register " [n]ot later than 9 months after date of enactment" - or by October 4, 2011 - with final rules to be adopted 9 months after close of comment period);
(3) regulations establishing science-based minimum standards for safe production and harvesting of fruits and vegetables, as required by 21 U.S.C. § 350h (notice of proposed final rulemaking to be published by January 4, 2012, with final regulation to be adopted within one year after close of final comment period);
(4) regulations to protect against intentional adulteration of food subject to FSMA, as required by 21 U.S.C. § 350i(b), in consultation with Secretary of Homeland Security and Secretary of Agriculture (regulations due " [n]ot later than 18 months after January 4, 2011" - or July 4, 2012);
(5) regulations regarding FDA requirement that shippers, carriers by motor vehicle or rail, receivers, and other persons engaged in transportation of food use sanitary transportation practices to ensure that food is not transported under conditions that might render it adulterated, as required by 21 U.S.C. § 350e(b) and note (regulations due by July 4, 2012);
(6) regulations regarding foreign supplier verification program, as required by 21 U.S.C. § 384a(c) (final ...